WO2000069365A2 - Appareil et procedes d'obturation de communications septales et occlusion de debit sanguin - Google Patents

Appareil et procedes d'obturation de communications septales et occlusion de debit sanguin Download PDF

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Publication number
WO2000069365A2
WO2000069365A2 PCT/US2000/013058 US0013058W WO0069365A2 WO 2000069365 A2 WO2000069365 A2 WO 2000069365A2 US 0013058 W US0013058 W US 0013058W WO 0069365 A2 WO0069365 A2 WO 0069365A2
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WO
WIPO (PCT)
Prior art keywords
plug
fingers
wherem
tubular portion
pluralities
Prior art date
Application number
PCT/US2000/013058
Other languages
English (en)
Other versions
WO2000069365A3 (fr
Inventor
Todd Allen Berg
Alex A. Peterson
William J. Swanson
Paul J. Hindrichs
Original Assignee
St. Jude Medical Cardiovascular Group, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St. Jude Medical Cardiovascular Group, Inc. filed Critical St. Jude Medical Cardiovascular Group, Inc.
Priority to AU48447/00A priority Critical patent/AU4844700A/en
Priority to EP00930666A priority patent/EP1179999B1/fr
Priority to DE60025601T priority patent/DE60025601T2/de
Publication of WO2000069365A2 publication Critical patent/WO2000069365A2/fr
Publication of WO2000069365A3 publication Critical patent/WO2000069365A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00579—Barbed implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A61B2090/3941—Photoluminescent markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers

Definitions

  • This invention relates to apparatus and methods for closing mtravascular defects and occluding blood flow
  • it relates to closing septal defects or holes found between the walls of the four heart chambers and occluding blood flow in sections of a patient's circulatory system
  • the heart chambers include left and right atrial chambers in the upper portion and left and right ventricular chambers in the lower portion Defects in these walls can be formed congen tally or can develop later n life An atrial septal defect (hereinafter,
  • ASD ventricular septal defect
  • the patent ductus is a pre-birth opening between the aorta and the pulmonary artery This opening usually closes naturally, but may remain open and cause oxygenated blood to flow back into the lungs
  • Another defects are the ductus artenosis and the patent foramen os ale (hereinafter, "PFO") At least fifty percent of stroke patients under 55 years old have a PFO
  • a transcatheter apparatus has a large delivery profile that limits application of the method to young patients and makes t difficult to match the apparatus to the mtracardiac or extracardiac cavity and can result in thrombosis, emboli , or d slodgement due to interference with blood flow
  • septal holes cause strokes by shunting clots from the right atrium to the left atrium From the left atrium , a clot can go to the brain
  • Occlusion can control internal bleeding and buffer pressure in the vicinity of an aneurysm
  • septal defects such as ASD , VSD , and PFO , that function at least as well as the proven surgical thin sewn patch , but which are less invasive
  • septal defect devices and occluding plugs that can be properly matched to the mtracardiac or extracardiac cavity It would be still further desirable to provide apparatus and methods for percutaneous delivery and deployment of occlusion devices for blocking blood flow n various sections of the circulatory system
  • t is an object of the invention to provide these apparatus and methods such that the delivery profile s small and such that they can be used to treat patients of havmg a wide range of ages
  • a plug for closing an aperture m a wall of a patient s body cavity
  • the plug includes a frame that has a central axis, a first plurality of fingers configured to engage an interior surface of the body cavity wall, a second plurality of fingers that are attached to the first plurality and are configured to engage an exterior surface of the body cavity wall , and a plugging structure
  • the fingers can be positioned substantially circumferentially about the central axis
  • the plugging structure s attached to the frame and spans the aperture when the plug s m position Furthermore, cross-sections of the frame that lie in a plane substantially perpendicular
  • a plug is provided that has a perforated tubular portion having a longitudinal passage Any cross-section of the perforated tubular portion taken along a plane perpendicular to the passage is substantially discontinuous to allow conformation of the portion to perimeter of the aperture
  • the plug has a plurality of fingers extending from each of the two axial ends of the perforated tubular portion Preferably, any cross- section of the fingers taken along a plane perpendicular to the passage is also substantially discontinuous
  • the plug also has a plugging structure as described above
  • an occlusive device is provided for occluding blood flow at a treatment site This device is similar to the preceding plugs , but has ingers extending from only one axial end of the perforated tubular portion Durmg operation, these fingers anchor the device to the internal surface of a blood vessel
  • methods for plugging an aperture n a wall of a patient's body cavity includes positioning a conformable plug m the aperture , conforming the plug to the aperture , and securing the plug in the aperture It will be appreciated that the steps of conforming and securing could occur at the same time Methods for occluding blood flow are also provided
  • FIG 1 is a plan view of a plug for plugging a septal defect in accordance with this invention
  • FIG 1A is a partial side elevational view along direction 1A-1A of FIG 1 in accordance with the principles of th s invention
  • FIG 2 is a side elevational view o' ' finger of a plug in accordance with th s invention
  • FIG 3 is a side elevational view of another finger of a plug in accordance with this invention
  • FIG 4 is a side elevational v ew of yet another finger of a plug in accordance with this invention
  • FIG 5 is a s de elevational view of still another finger of a plug n accordance with this invention .
  • FIG 6 is a plan view of another plug for plugging a septal defect in accordance with this invention
  • FIG 7 is a side elevational view of yet another finger of a plug in accordance with this invention .
  • FIG 8 is a plan view of yet another plug for plugging a septal defect in accordance with this mvention .
  • FIG 9 is a plan view of yet another plug for plugging a septal defect m accordance with this invention
  • FIG 10 is a cross-sectional view of a plug for plugging a septal defect disposed within a delivery device in accordance w th th s invention
  • FIG 11 is a cross-sectional view of the plug shown m FIG 10 when the plug is partially deployed in the septal defect in accordance with this invention
  • FIG 12 is a cross-sectional view of the plug shown in FIG 10 and 11 when the plug is fully deployed in the septal defect in accordance with this invention .
  • FIG 13 is a cross-sectional view of a plug similar to the one shown m FIGS 10-12 when the plug is fully deployed showing the delivery path of a delivery device in accordance w th th s invention ,
  • FIG 14 is a cross-sectional view of the plug shown in FIG 13 for plugging a septal defect when the plug is fully deployed and the delivery device has been retracted from the heart in accordance with this inventio ,
  • FIG 15 is an elevational view of the plug shown in FIGS 13 and 14 taken along lme 15-15 of FIG 14 in accordance with this invention .
  • FIG 16 is a plan view of yet another plug for plugging a septal defect n accordance with this invention .
  • FIG 17 is a plan view of the plug shown in FIG 16 from the opposite side n accordance with this invention
  • FIG 18 is a cross-sectional view of the plug shown m FIGS 16 and 17 when the plug is fully deployed in the septal defect n accordance w th this invention ,
  • FIG 19 is a plan view of the plug shown in FIGS 16-18 taken from lme 19-19 of FIG 18 in accordance with this invention .
  • FIG 20 is a partial elevational view of an unrolled frame for an illustrative plug n accordance with this invention
  • FIG 21 s a perspective view of the of the frame shown in FIG 21 with ends attached (showing only a single finger at each axial end of the frame) in accordance w th this invention
  • ends attached shown only a single finger at each axial end of the frame
  • FIG 22 is a cross-sectional v ew of the frame shown in FIGS 20 and 21 with ends attached in accordance with this invention ,
  • FIG 23 is an elevational view of the frame shown in FIG 22 in accordance with this invention.
  • FIG 24 s a perspective view of the frame shown in FIG 21 with an attached plugging structure to form a plug in accordance with this mvention ,
  • FIG 25 is an elevational v ew of the plug shown n FIG 24 (showing a number of forward facing fingers) after the fingers have been bent into the wall- engaging position in accordance with this invention
  • FIG 26 is a partial elevational v ew of an unrolled frame with a plugging structure in accordance with this invention .
  • FIG 27 is an elevational view of another unrolled frame for a plug in accordance with th s mvention
  • FIG 28 s an elevational v ew of another plug mounted on a delivery balloon in accordance with th s mvention
  • FIG 29 s a cross-sectional view taken of the plug shown in FIG 28 in position for deployment in a defect in accordance with this invention
  • FIG 30 is a cross-sectional view of the plug shown in FIGS 28 and 29 when the plug s deployed in the defect in accordance w th this invention ,
  • FIG 31 is a cross-sectional view of the plug shown in FIGS 28-30 in position for deployment showing the delivery path of a delivery device in accordance with this invention .
  • FIG 32 is a cross-sectional view of yet another plug for plugging a septal defect when the plug s fully deployed in the septal defect m accordance with th s invention ,
  • FIG 33 is a partial elevational view of an unrolled frame for an occlusion device (I e , a plug) n accordance with this invention
  • FIG 34 is an elevational view of another occlusion device w th barbs mounted on a delivery balloon in accordance with this invention
  • FIG 35 s a partial elevational view of another occlusion device for occluding a section of a blood vessel in accordance with this invention .
  • FIG 36 is a cross-sectional view of the occlusion device shown n FIG 35 deployed in a blood vessel n accordance with th s invention
  • the invention provides apparatus and methods for preventing the flow of body fluids through apertures in body cavity walls and through a patient's body tubing, such as a blood vessel
  • the apparatus can be a plug that is installed in the patient's body using an mtraluminal catheter method
  • the plug can have a (1) frame that conforms to the walls of an aperture (e g , a defect) or a section of tubing and (2) a plugging structure (e g , a patch) that prevents the flow of fluid
  • the plug can be installed in a variety of types of body tissues to prevent the low of body fluid , only embodiments of the mvention related to preventing the flow of blood through passageways n the circulatory system will be illustrated herein
  • a plug for closing an aperture or hole in a septal wall of a patien ' s heart , for example a PFO
  • the plug has a frame, two pluralities of fingers attached to axial ends of the frame and to each other, and a plugging structure attached thereto
  • the pluralities of fingers can be integral with the frame and formed from a unitary body During operation, one plurality of fingers engages an interior surface of the wall and the other set of fingers engages the opposite , or exterior , surface
  • the plugging structure s supported by the frame and spans the aperture (e g , defect) to prevent the flow of blood there through
  • the fingers are preferably positioned substantially circumferentially (l e , peripherally) about the plug s central axis , which passes through the frame
  • the fingers can extend radially away or along the axis
  • the fingers have ends that are radially proximal to the central ax s and which generally define a substantially round or elliptical broken cross-section in a plane substantially perpendicular to the central axis
  • any cross section of tb frame that l es in a plane substantially perpendicular to the axis s substantially discontinuous allows the frame to contract and expand radially as necessary for insertion mto a delivery device, placement n an aperture, and conformation to the walls of the aperture
  • the frame itself can comprise an elastic material , such as ni mol
  • the frame can comprise a plastically deforming material , such as stainless steel
  • the elastic and plastic embodiments may be delivered differently
  • the frame may be equipped with one or more marker structures , which can be radiopaque , to help identify, locate, and orient the plug using images produced with , for example , X-rays, CT scans, ultrasound, and echo techniques
  • Marker structures can be provided in a variety of forms
  • a marker structure can be in the form of a marker band made from a radiopaque material that is crimped onto an end portion of a finger
  • a marker structure can be a rivet that is inserted and locked into a ring or hole a finger If marker structures are used, they can be provided on any number of fingers
  • a finger can be provided with a retention device receptacle
  • a retention device reciprocates withm a delivery sleeve or catheter and engages the fingers while the plug is inserted n the delivery sleeve so that the plug can be reciprocated within the sleeve and shifted into position in the aperture, such as a PFO Once n position, the retention device can release the fingers so that the fingers spring mto engagement w th the aperture wall
  • the retention device itself has fingers or locking pins that engage the retention device receptacles that reside on the ends of the frame fingers
  • Retention device receptacle include, but are not limited to, locking p n apertures and nose cone covers
  • Fingers may have a variety of designs that are tailored to optimize plug security for the shape and tissue characteristics of a given PFO
  • fingers can have pointed ends , barbs , or curved portions
  • fingers can be curved toward a plane that is perpendicular to the central axis and that passes substantially between the two pluralities of fingers Fingers can be of substantially similar length or substantially different lengths Any finger can have different flexural stiffness at different points along its length
  • One way to accomplish differential flexural stiffness of a finger is to provide a finger having a different thickness or a different width at different points along its length Alternatively, both the finger thickness and the finger width can vary along the length of a given finger, if desired
  • the force applied by a finger to the septum wall can be distributed to minimize stress concentration m the wall
  • the plug can be provided with an elastic web supported between adjacent fingers
  • the web for example, can mclude silicone
  • the plugging structure that occludes the PFO can be attached to or supported by the frame at proximal or distal ends of the fingers In either case, the fingers ends can be provided with support structures with which the plugging structure can be affixed
  • the plugging structure is made from an elastic material and can contract and expand as the frame contracts and expands (e g , during delivery and deployment)
  • an elastic material that can be used to make the plugging structure is polyester (such as the material sold under the trademark DACRON® by E I du Pont de Nemours & Company of Wilmington , Delaware )
  • the plugging structure can also be made from cloth and be folded and unfolded as the plug is contracted and expanded as may be necessary for its installation in the defect
  • the plugging structure can be attached (e g , sewn) directly to the frame
  • the plugging structure can have a guide wire aperture through which a guide wire can pass If the guide wire is inserted to the patient prior to plug delivery, the guide wire can be used to guide the plug mto place in the PFO
  • the guide wire aperture can be designed to substantially self close after the guide wire is removed from the guide w re aperture
  • the self- closing feature can be achieved by making the diameter of a guide wire aperture in the relaxed state (1 e , without the wire) small enough to induce clotting and close off blood flow
  • the plug has a perforated tubular portion that forms a longitudinal passage Fingers extend from each of the two axial ends of the perforated tubular portion and may be provided in a variety of configurations and made from a variety of materials Any of the features discussed above may
  • the plugging structure can be supported directly or indirectly by the perforated tubular portion
  • the plugging structure can be attached directly to the perforated tubular portion or to elements of the structure (such as tabs, bosses, extensions, or loops)
  • the plugging structure can be attached via interceding support structures (such as attachment rings, clips, or loops) that connect the tubular portion to the plugging structure
  • the perforated tubular portion preferably contracts longitudinally as it expands radially.
  • the tubular portion can be made of a material that deforms plastically or elastically
  • a plastically deforming material can be , for example , stainless steel or tantalum
  • the plug is installed by positioning the plug in the aperture of the PFO and expanding a balloon inside the plug to at least partially conform the perforated tubular portion to the perimeter of the aperture
  • the perforations allow the plug to contract longitudinally m response to the radial expansion
  • the longitudinal contraction causes the fingers to engage opposing sides of the wall
  • an occlusion plug has a perforated tubular portion for occluding a blood vessel Th s type of plug may be desirable to prevent blood flow near a damaged portion of the vessel (e g , aneurysm)
  • the occlusion plug can be plastically or elastically deformable
  • the occlusion plug is installed in the blood vessel by expanding a balloon m a longitudinal passageway of the perforated tubular portion
  • the expansion of the balloon causes the plug to expand radially and contract longitudinally
  • This expansion causes the outer surface of he perforated tubular portion to conform to the inner surface of the lumen of the blood vessel
  • the expansion also causes the fingers at the end of the perforated tubular portion to engage the inner surface of the wall as they are driven radially outward from the longitudinal axis and drawn longitudinally toward the perforated tubular p Lion
  • the fingers of the occlusion plug pre erably extend from only one axial end of the perforated tubular portion
  • the configuration of the fingers , the structures associated with the ingers, the perforated tubular portion , and the relation of the fingers to the perforated tubular portion are similar to those described above in connection with the PFO plug
  • the invention also includes methods for preventing the flow of body fluids through apertures n body cavity walls
  • a plug that is at least partially made from an elastic material and is conformable to a defect such as any of those elastic plugs described above having two opposing pluralities of fingers, is positioned at the defect, conformed to the perimeter of the defect and secured thereto
  • a delivery structure with a sleeve is provided Durmg the process of positioning the plug , the plug fingers are extended in a direction that is substantially parallel to the central axis of the plug while the plug is inserted into the sleeve of the delivery structure
  • a retention device inside the sleeve engages at least some of the extended fingers at the finger ends
  • the retention device can use locking pms , hooks , or any other means to retain the plug inside the sleeve
  • the retention elements permit an operator to reciprocate the plug longitudinally with respect to the sleeve and to shift the plug out from the end of the sleeve
  • the sleeve can be inserted like a catheter through an insertion aperture in a patient s body tissue
  • the sleeve can then be passed through the patient's internal body tubing or other body structures until the end of the sleeve is positioned withm or adjacent the PFO for plug delivery
  • the delivery structure can be shifted relative to the plug and the PFO, thereby removing the delivery structure from the PFO
  • the plug extends through the PFO and the plug fingers extend outward , preferably radially , from the central axis of the plug on opposite sides of the wall in which the PFO resides This causes the plug fingers to engage the wall and the plugging structure to substantially occlude the PFO
  • releasing the plug withm the PFO allows the plug to expand elastically inside the PFO until the plug substantially conforms to the inner rim or perimeter of the PFO
  • the plug is allowed to elastically contract along the central axis of the plug while it expands radially Th s longitudinal contraction causes the fingers to engage opposite sides of the same wall of the body cavity
  • a plastically deformable plug can be mserted m a PFO using a balloon
  • a conformable plug such as any of those plastically deformable plugs described above , is positioned in the PFO , conformed to the perimeter of the PFO , and then secured thereto
  • the positioning can be achieved by inserting a delivery balloon into the tubular portion of the plug and delivering both through a patient's body tissue, (e g , through an insertion aperture and blood vessels) , to the PFO Then, the balloon, which supports the plug, is moved through the patient's body until the plug is appropriately positioned in the aperture -- such that one plurality of fingers is situated on each side of the wall
  • FIGS 1-36 shows plug 100 for closing an aperture, such as an ASD, a VSD, or a PFO, n a wall of a patient's body cavity Frame 102 can be made from an elastic material
  • frame 102 allows frame 102 to radially contract sufficiently to allow it to be mserted mto an aperture and subsequently radially expand to conform to the inner perimeter of the aperture
  • Other elastic materials can also be used to construct the frame and could be used in combination w th other non-elastic materials Radial expandability s facilitated by constructing the frame such that any cross section perpendicular to its central axis is discontinuous
  • Frame 102 has central axis 104 and supports plugging structure 106
  • Frame 102 includes first plurality of fingers 108 and second plurality of fingers 110
  • fingers 108 are integral with fingers 110
  • Fingers 108 and 110 have proximal ends 120 that are near central axis 104 and remote ends 112 that are near the radially outer portions of frame 102
  • Proximal ends 120 can be used to support plugging structure 106 directly or they can be equipped with support structures 130 for supporting plugging structure 106 Alterna ively, remote ends 112 can support plugging structure 106 Remote ends 112 can also be equipped with support structures 113 for supporting plugging structure 106, and, as discussed more fully below, marker devices The ends can also be adapted to engage a retention device during plug installation In FIG 1, each support structure 113 has aperture 114 to which a plugging structure can be sewn or otherwise attached
  • Plugging structure 106 can be made from an elastic material Plugging structure 106 can also be folded and unfolded to allow frame 102 to deform during insertion mto the aperture
  • a foldable and unfoldable plugging structure can be either elastic or non-elastic and may include a cloth or polymeric material
  • plugging structure 106 is made of polyester Plugging structure 106 can include guide wire aperture 140 for insertion of a guide wire (not shown) during installation of the plug in a patient Guide wire aperture 140 may be self-closing after the removal of a guide wire
  • the self closing feature may be effected by the elasticity of plugging structure 106
  • the woven fibers under tension from frame 102 can automatically close guide w re aperture 140
  • Remote ends 112 can also be provided with retention device receptacles for engaging a retention device that is part of a system for delivering the plug to an aperture in a wall
  • Finger aperture 114 can be used as a retention device receptacle
  • FIG 1A shows a partial s de view of plug 100 with fingers 108 and 110 in an intermediate con iguration without plugging structure 106
  • FIG 1A shows a partial s de view of plug 100 with fingers 108 and 110 in an intermediate con iguration without plugging structure 106
  • FIGS 2-5 show different features that can be incorporated mto a finger FIG 2, for example, shows a side view of finger 208 , having proximal end 220 and remote end 212, with rivet 214 mounted thereto Rivet 214 can be mounted on
  • FIG 6 shows another embodiment of a plug constructed in accordance w th this invention in which proximal ends 620 of fingers 608 and 610 define substantially elliptical cross section 650 Elliptical cross section 650 is in contrast to round cross- section 150 shown in FIG 1
  • central axis 604 passes near the center point of the ellipse plugging structure 606 , which s supported by proximal ends 620, has a substantially elliptical shape and could have a guide wire aperture (not shown) , if desired
  • FIG 7 shows an example of finger 708 , which has proximal end 720 and distal end 712 Finger 708 tapers from thickness ⁇ at proximal end 720 to lesser thickness t 2 at end 712 (e g , remote from the plug's central axis) Conversely, finger 708 may be thicker at the remote end and thinner at the proximal end
  • a finger such as finger 708
  • Fingers of varying width such as the fingers shown in FIG 1
  • FIG 8 shows another illustrative embodiment of a plug constructed according to this invention in which fingers 808 and 810 have lengths that vary with respect to each other Although fingers 808 and 810 have different lengths, it will be appreciated that plugging structure 806 can have a substantially circular, or any other convenient, shape
  • FIG 9 shows another alternative embodiment of a plug constructed according to this invention in which elastic web 907 spans between adjacent fingers of a plurality of fingers 908 The web can be made from any elastic material, including silicone Plugging structure 906 is supported by proximal ends of fingers 908 and 910, and can be supported by support structures 930
  • FIG 10 shows how a plug, such as plug 100, can be installed v a a delivery device, such as delivery catheter 1090
  • Plug 100 is inserted into delivery catheter 1090 by orienting fingers 108 and 110 n a direction that is substantially parallel to central axis 104
  • plug 100 is passed through to distal opening 1010
  • Optional marker rivets 114 are shown in FIG 10
  • plugging structure 1006 can be any convenient type
  • plugging structure 1006 is shown as a folded plugging structure
  • Retention device receptacles 1016 are engaged with locking pms 1022 of retention device 1092
  • plug 100 can be inserted into aperture 1180 in wall 1150 of a patient's body cavity, as shown in FIG 11 Initially, end 1122 of delivery catheter 1090 is positioned within aperture 1180 (indicated by a dashed lme) Delivery catheter 1090 is then partially reciprocated away from aperture 1180 along axis 1104 and with respect to retention device 1092 (indicated by solid).
  • catheter 1090 After catheter 1090 s partially reciprocated as shown in FIG 11, catheter is further reciprocated as shown in FIG 12 End 1122 is withdrawn past locking pms 1022 and retention device receptacles 1016 This allows fingers 108 to spring out radially away from central axis 1104 (from a position indicated by the dashed lines) and engage patient's cavity wall 1150 at surface 1148 As shown in FIG 12 foldable plugging structure 1006 at least partially unfolds to span aperture 1180
  • FIG 13 shows plug 1300 partially installed in aperture 1380 in wall 1350 of heart 1370
  • Plug 1300 of FIG 13 corresponds roughly to plug 100 of FIG 11
  • Delivery catheter 1390 and retention device 1392 are guided to wall 1350 by delivery guide 1394
  • fingers 1310 are deployed and engaged with surface 1346 of wall 1350
  • Fingers 1308 remain in delivery catheter 1390
  • Plugging structure 1306 is positioned inside aperture 1380 and is ready to conform to perimeter 1398 of aperture 1380 when the remainder of plug 1300 is released from retention device 1392
  • FIG 14 shows plug 1300 fully installed in aperture 1380 in heart 1370 so that plugging structure 1306 spans aperture 1380 and frame 1302 conforms to perimeter 1398 Fingers 1308 and 1310 are engaged with opposite sides of wall 1450 to secure plug 1300
  • Optional markers 1314 are provided on ends 1312 of fingers 1310
  • markers 1314 are radiopaque
  • FIG 15 shows plug 1300 as installed in wall 1350 as viewed along direction 15-15 of FIG 14 Fingers 1308 are pressing against surface 1348 of wall 1350
  • Plugging structure 1306 spans the aperture in wall 1350 and is substantially flush w th perimeter 1398
  • FIG 16 shows another embodiment of a plug according to the invention
  • Plug 1600 includes frame 1602 which is structurally similar to frame 102 of FIG 1 In this embodiment however, plugging structure 1606 is supported by remote ends 1612 of fingers 1608 It will be appreciated that plugging structure could just as easily be mounted on fingers 1610
  • Optional marker rivets (not shown) can be placed in or near the apertures located at the of ends of fingers 1612
  • FIG 18 shows plug 1600 fully installed n aperture 1880 of wall 1850 in patient s heart 1870
  • Plugging structure 1606 is attached to remote e 1-s 1612 of fingers 1608 and is drawn against surface 1 ">48 by fingers 1612 as fingers 1608 press against side 1848
  • When installed plugging structure 1606 has a greater diameter than cavity wall aperture 1880 and thus extends beyond perimeter 1898 of aperture 1880 in order to occlude aperture 1880
  • Fingers 1610 engage side 1846 of wall 1850 and hold plug 1600 in position
  • FIG 19 shows plug 1600 as viewed from line 19 19 of FIG 18 Fingers 1610 of frame 1602 are not shown because from this perspective they are behind wall 1850 Perimeter 1898 of aperture 1880 s shown as a broken line because it is behind plugging structure 1606
  • Plugging structure 1606 can be supported by rivets 1614 which are located at ends 1612
  • a plug has a medial portion that defines a central passage with a central axis To allow the medial portion to expand radially, any cross-section of that portion (and preferably the entire frame) taken perpendicularly to the central axis is substantially discontinuous
  • FIG 20 shows frame 2002 in an "unfurled' state Portions 2051 and 2052 of medial section 2050 would normally be connected so that medial section 2050 forms a perforated tube surrounding the plug's central ax s
  • Plug 2000 can include retention device receptacles 2016 on, for example , remote ends of the fingers
  • Frame 2002 can also mclude support structures 2030 for supporting a plugging structure (
  • FIG 22 shows a cross-sectional view of perforated tubular portion 2050 taken along a plane that s perpendicular to central ax s 2004
  • the broken lme corresponding to portion 2050 indicates that the cross section is discontinuous
  • FIG 23 shows a side view of tubular portion 2050 and selected fingers 2008 and 2010 in two different positions
  • fingers 2008 and 2010 are attached to the axial ends of tubular portion 2550 and are bent away from central axis 2004 into a splayed position
  • These fingers can be heat treated before the plug is installed to cause them to relax in th s splayed position
  • Fingers 2008 and 2010 can also be positioned so that they point in a direction that is substantially parallel to central ax s 2004 (as shown by dashed lmes which corresponds to the view of FIG 22) for installation of the plug This position can be achieved , for example, by inserting the plug mto a delivery device
  • FIGS 24 and 25 are similar to FIGS 21 and 23, respectively, but now include plugging structure 2006 mounted to frame 2002
  • a plugging structure can be supported by support structures 2013 of fingers 2008 and/or 2010
  • plug 2000 can include two plugging structures , each of which can be supported by support structures located at opposite axial ends of plug 2000
  • plug 2600 which includes frame 2602
  • Frame 2602 mcludes first plugging structure 2606 , which is mounted on support structures 2613 of fingers 2610 and second plugging structure 2607 , which is mounted on support structures 2613 of fingers 2608
  • Support structures 2613 can also be used to mount markers or engage a retention device
  • a frame having a perforated tubular portion can be formed from a plastically deformable material and can be installed using a balloon FIG 27, for example, shows frame 2702 in an unfurled state similar to the configuration of frame 2002 in FIGS 20 and 26 In use, end portion 2751 and 27
  • FIG 28 shows plug 2800, which includes frame 2802 with delivery balloon 2888 inserted in longitudinal passage 2856 Delivery balloon 2888 is inflated enough to engage frame 2802 and allow delivery of plug 2800 to a repair site inside a patient Folded or elastic plugging structure 2806 s deflected around t p 2889 of balloon 2888 Plugging structure 2806 is attached to frame 2802 at support structure 2830 Plug 2800 can have barbs 2815, for example, for engaging a patient s body tissue
  • FIG 29 shows a cross-sectional view of plug 2800 bemg positioned in aperture 2980 in cavity wall 2950 .
  • balloon 2888 engages the inside of frame 2802 Plugging structure 2806 s deflected around balloon t p 2889
  • plug 2800 is inserted with balloon 2888 mto aperture 2980
  • Balloon 2888 is then inflated, causing frame 2802 to expand radially and to contract along ts central axis 2804, thereby forcing barbs 2815 to pierce opposite sides 2946 and 2948 of wall 2950
  • This also causes perforated tubular portion 2852 to conform to perimeter 2898 If plugging structure 2806 s secured to perforated tubular portion 2852 , t too s stretched or unfolded across aperture 2980
  • FIG 30 shows plug 2800 installed in aperture 2980 after frame 2802 is deformed by the expansion of balloon 2888 At th s stage, balloon 2888 has been removed from perforated tubular portion 2852
  • the perforations ( e , the holes) in portion 2852 allow the axial length of perforated tubular portion 2852 to decrease as its radius increases
  • FIG 31 shows plug 2800 being delivered to aperture 2980 in heart 2970
  • Plug 2800 is supported by partially inflated balloon 2888 and guided through a patient's body tissue and/or tubing via delivery guide 2894 until it s positioned with barbs 2815 on opposite sides of wall 2950
  • plug 2800 can be fully installed by further expanding balloon 2888 , thereby causing frame 2802 to deform and secure itself as shown in FIG 32
  • balloon 2888 s deflated and removed
  • tubular portion 2852 conforms to perimeter 2998 and plugging structure 2806 spans and occludes blood flow through the aperture
  • FIG 33 shows occlusion plug 3300, which includes frame 3302
  • Plug 3300 is similar to aperture plug 2700 (shown in FIG 27) , but has barbs (or points) that extend from fingers 3308 on only one axial end 3305 of medial section 3350 It w ll be appreciated that points 3315 are not always necessary, but may ! _' mcluded in plugs where positive anchoring is desired
  • Frame 3302 is shown in FIG 33 in an unfurled' state, but as in the embodiments discussed above, would be joined to form a perforated tubular portion
  • Support structures 3330 can also be provided for securing a plugging structure (not shown)
  • FIG 34 shows occlusion plug 3400 mounted on partially inflated balloon 3488
  • Balloon 3488 occupies longitudinal passage 3456 along central axis 3456
  • Plugging structure 3406 is attached to frame 3402 at support structures 3430 in medial section 3452 and is deflected around tip 3489 of balloon 3488 Piercing points 3415, which can be barbed, extend away from central axis 3456 and are destined to be embedded in the interior wall of a patient's body tubing
  • Occlusion plug 3500 which is shown FIG 35, is constructed according to this mvention , but includes a frame with a different profile from that shown in
  • FIG. 33 shows a partial view of plug 3500 n the unfurled state
  • medial portion 3550 can radially expand and axially contract when a balloon is inflated therein
  • each of the rectangular units that make up frame 3502 can stretch, such that length 1 and width w vary inversely
  • FIG 36 shows the deployment of occlusion plug 3600 in a patient's blood vessel 3640 having aneurysm 3650
  • Arrow A shows the normal direction of blood flow through blood vessel 3640
  • plug 3600 is mounted on balloon 3688 and positioned upstream of aneurysm 3650
  • balloon 3688 is inflated
  • perforated tubular portion 3652 expands radially causing perforated tubular portion 3652 to conform to inner wall 3642 of blood vessel 3640
  • Plugging structure 3606 is attached to frame 3602 at points along the circumference of tubular portion 3652 and is thus stretched to occlude lumen 3644 of blood vessel 3640
  • perforated tubular portion 3652 expands radially, it contracts axially and causes piercing points 3615 to engage walls 3642 and thus anchor plug 3600

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Abstract

La présente invention concerne des bouchons d'obturation et des procédés d'obturation de communications septales et de vaisseaux sanguins. Des bouchons d'obturation sont amenés au moyen d'un cathéter jusqu'à une communication septale ou un endroit où on désire obturer un débit sanguin dans un vaisseau sanguin. Les bouchons d'obturation sont placés et déployés dans le site de traitement. Le déploiement des bouchons d'obturation peut se faire de manière passive au moyen d'une structure élastique traitée thermiquement, ou de manière active au moyen d'un ballonnet pour déformer une structure de déformation plastique. Les structures d'obturation montées sur ladite structure traversent la communication ou la lumière de part et d'autre et empêchent le sang de s'écouler. Ces bouchons d'obturation présentent de petits profils et sont plus fiables que les procédés à transcathéter intraluminal précédents.
PCT/US2000/013058 1999-05-13 2000-05-12 Appareil et procedes d'obturation de communications septales et occlusion de debit sanguin WO2000069365A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU48447/00A AU4844700A (en) 1999-05-13 2000-05-12 Apparatus and methods for closing septal defects and occluding blood flow
EP00930666A EP1179999B1 (fr) 1999-05-13 2000-05-12 Appareil pour l'obturation de communications septales ou occlusion de debit sanguin
DE60025601T DE60025601T2 (de) 1999-05-13 2000-05-12 Verschlusseinrichtung eines septumschadens

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13425099P 1999-05-13 1999-05-13
US60/134,250 1999-05-13

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WO2000069365A2 true WO2000069365A2 (fr) 2000-11-23
WO2000069365A3 WO2000069365A3 (fr) 2001-03-08

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AT (2) ATE315915T1 (fr)
AU (1) AU4844700A (fr)
DE (2) DE60025231T2 (fr)
WO (1) WO2000069365A2 (fr)

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EP1222897A3 (fr) * 2001-01-12 2004-01-02 ev3 Inc. Dispositif de fermeture d'un défaut septal
EP1470785A1 (fr) * 2003-04-24 2004-10-27 Medtronic Vascular, Inc. Dispositif pour faire un trou dans une membrane
EP1602332A1 (fr) * 2001-08-01 2005-12-07 ev3 Inc. Dispositif d'occlusion
US6991643B2 (en) 2000-12-20 2006-01-31 Usgi Medical Inc. Multi-barbed device for retaining tissue in apposition and methods of use
US7160312B2 (en) 1999-06-25 2007-01-09 Usgi Medical, Inc. Implantable artificial partition and methods of use
EP1923019A1 (fr) 2006-11-20 2008-05-21 Stout Medical Group LP Dispositif et procédé d'empêchement le debit de l'embolie non souhaité entre veines et artères
US7530963B2 (en) 2003-04-24 2009-05-12 Wisconsin Alumni Research Foundation Method of maintaining patency of opening in third ventricle floor
WO2012134762A1 (fr) 2011-03-25 2012-10-04 Aga Medical Corporation Dispositifs et méthode d'occlusion d'une malformation septale
EP2886083B1 (fr) 2012-03-23 2018-05-16 Sorin Group Italia S.r.l. Prothèse de valvule repliable
US10434293B2 (en) 2012-04-15 2019-10-08 Tva Medical, Inc. Implantable flow connector
CN110621236A (zh) * 2017-05-16 2019-12-27 爱德华兹生命科学公司 跨间隔闭合装置
US10632293B2 (en) 2012-04-15 2020-04-28 Tva Medical, Inc. Delivery system for implantable flow connector
US10987106B2 (en) 2007-08-02 2021-04-27 Tva Medical, Inc. Implantable flow connector

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US10531867B2 (en) 2017-02-13 2020-01-14 Muath Alanbaei Sinus venosus atrial septal defect treatment device
US11395644B2 (en) 2017-02-13 2022-07-26 Gulf Medical Technologies Sinus venosus atrial septal defect treatment device
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Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7160312B2 (en) 1999-06-25 2007-01-09 Usgi Medical, Inc. Implantable artificial partition and methods of use
US6991643B2 (en) 2000-12-20 2006-01-31 Usgi Medical Inc. Multi-barbed device for retaining tissue in apposition and methods of use
EP1955661A3 (fr) * 2001-01-12 2008-10-01 ev3 Endovascular, Inc. Dispositif de fermeture d'une malformation septale
EP1222897A3 (fr) * 2001-01-12 2004-01-02 ev3 Inc. Dispositif de fermeture d'un défaut septal
EP1602332A1 (fr) * 2001-08-01 2005-12-07 ev3 Inc. Dispositif d'occlusion
EP1470785A1 (fr) * 2003-04-24 2004-10-27 Medtronic Vascular, Inc. Dispositif pour faire un trou dans une membrane
US7530963B2 (en) 2003-04-24 2009-05-12 Wisconsin Alumni Research Foundation Method of maintaining patency of opening in third ventricle floor
EP1923019A1 (fr) 2006-11-20 2008-05-21 Stout Medical Group LP Dispositif et procédé d'empêchement le debit de l'embolie non souhaité entre veines et artères
JP2008126060A (ja) * 2006-11-20 2008-06-05 Stout Medical Group Lp 機械的組織デバイスおよび方法
EP2263605A1 (fr) * 2006-11-20 2010-12-22 SeptRx, Inc. Dispositif et procédé d'empêchement le debit de l'embolie non souhaité entre veines et artères
US10987106B2 (en) 2007-08-02 2021-04-27 Tva Medical, Inc. Implantable flow connector
WO2012134762A1 (fr) 2011-03-25 2012-10-04 Aga Medical Corporation Dispositifs et méthode d'occlusion d'une malformation septale
AU2012238091B2 (en) * 2011-03-25 2016-05-19 St. Jude Medical, Cardiology Division, Inc. Devices and method for occluding a septal defect
EP2688486A4 (fr) * 2011-03-25 2015-03-18 Aga Medical Corp Dispositifs et méthode d'occlusion d'une malformation septale
EP2886083B1 (fr) 2012-03-23 2018-05-16 Sorin Group Italia S.r.l. Prothèse de valvule repliable
EP2886083B2 (fr) † 2012-03-23 2024-06-19 Corcym S.r.l. Prothèse de valvule repliable
US10434293B2 (en) 2012-04-15 2019-10-08 Tva Medical, Inc. Implantable flow connector
US10632293B2 (en) 2012-04-15 2020-04-28 Tva Medical, Inc. Delivery system for implantable flow connector
US11541213B2 (en) 2012-04-15 2023-01-03 Tva Medical, Inc. Delivery system for implantable flow connector
US11666737B2 (en) 2012-04-15 2023-06-06 Tva Medical, Inc. Implantable flow connector
CN110621236A (zh) * 2017-05-16 2019-12-27 爱德华兹生命科学公司 跨间隔闭合装置
CN110621236B (zh) * 2017-05-16 2023-10-10 爱德华兹生命科学公司 跨间隔闭合装置

Also Published As

Publication number Publication date
EP2108315A2 (fr) 2009-10-14
EP2108315B1 (fr) 2017-09-06
DE60025601T2 (de) 2006-07-20
WO2000069365A3 (fr) 2001-03-08
EP1179999B1 (fr) 2006-01-18
ATE315915T1 (de) 2006-02-15
DE60025231T2 (de) 2006-07-13
AU4844700A (en) 2000-12-05
DE60025601D1 (de) 2006-04-06
DE60025231D1 (de) 2006-02-02
EP2108315A3 (fr) 2010-12-22
ATE314010T1 (de) 2006-01-15
EP1179999A2 (fr) 2002-02-20

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